NL-OMON42930CompletedNot Applicable
DUPLO study: Comparison of the microbial composition of the upper gastrointestinal tract in lean and obese subjects<br> - DUPLO-study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Danisco Sweeteners Oy
- Enrollment
- 22
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •* Age: 25-50y; In case of sufficient eligible subjects, the age distribution of the two groups will be aligned, and the age range will be reduced to max. 10 y between highest and lowest age.
- •* Lean: BMI 19-23 kg/m2, waist circumference <80 cm, and fasting glucose <6.1 mmol/L; Obese: BMI 30-35 kg/m2, waist circumference >88 cm, and fasting glucose ><=6.1 and <7.5 mmol/L
- •* Healthy as assessed by the NIZO lifestyle and health questionnaire (*Verklaring leefgewoonten en gezondheid*)
- •* Healthy as assessed by results of the pre-study safety laboratory tests (clinical chemistry: liver/kidney function etc).
- •* Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day)
- •* Regular bowel movement (defecation on average once a day, at least 4 times/week)
Exclusion Criteria
- •* Participation in any clinical trial with oral, intravenous or inhalatory administration of any substances during 90 days before study start
- •* History or presence of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject*s ability to participate in the study:
- •o type 1 or type 2 diabetes
- •o gastrointestinal disease
- •o bariatric surgery
- •o cardiovascular disease, liver or renal failure or disease of kidney or thyroid gland, cancer
- •o infectious disease, history of chronic active inflammatory disorders, food allergy
- •* Use of antibiotics during the one (1) year prior to study start: if this criterion restricts inclusion too much, we will lower this timeframe to six (6) months.
- •* Constipation/infrequent bowel movement (defecation <4 times per week)
- •* Having diarrhea within 3 months prior to the study start
- •* Use of laxatives, fiber supplements (e.g. lactulose), glucose lowering drugs, insulin, anti-obesity drugs, immunosuppressive drugs (e.g. systemic corticosteroids, cyclosporine, azathioprine, antibodies) during the three (3) months prior to study start
- •* Use of temporary or irregular medication for diabetes, dyslipidemia or hypertension
- •* Use of any prescribed or non-prescribed medication (other than paracetamol) including antacids, analgesics, H2 receptor antagonists, proton pump inhibitors, herbal remedies or anti-inflammatory drugs (e.g. NSAIDs) during the three (3) weeks prior to study start.
- •* Use of pro- or prebiotics during the three (3) months prior to study start
- •* Mental status that is incompatible with the proper conduct of the study
- •* Presence of swallowing or passage disorder
- •* Carrying a pacemaker or any other (implanted) medical electronic device
- •* Scheduled for an MRI scan during the study period
- •* Not willing to have an X-ray if the capsule is not recovered from the faeces
- •* Alcohol consumption > 15 units/week and >3/day, and/or not willing to stop during the study
- •* Drug abuse, and not willing/able to stop this during the study
- •* Heavy exercise or sports training > 10 hours/week
- •* Active or recent participation in a weight loss program including weight change (increase or loss) of >3 kg during the last three (3) months
- •* Reported unexplained weight loss or weight gain of > 5 kg in the year prior to pre-study screening
- •* Reported slimming or medically prescribed diet
- •* Reported special diets such as vegetarian, vegan, macrobiotic, low carbohydrate, dairy-free, or diets with intention to use certain limited food groups only (e.g. paleo diet, egg-grape diet)
- •* Pregnant or planning to become pregnant during the study, breastfeeding (subjects will be asked to perform a urine pregnancy test on the study day, before swallowing the caspule)
- •* Postmenopausal women on unstable hormone replacement therapy (periodical hormone treatment such as contraceptives is no exclusion criterion)
- •* Not willing to accept information-transfer concerning participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
Investigators
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